FDA product code GYA: Tester, Electrode/Lead, Electroencephalograph
GYA is the FDA product code for tester, electrode/lead, electroencephalograph. It is a Class I device, regulated under 21 CFR 882.1410 and reviewed by the Neurology panel. FDA has cleared 5 510(k) submissions under GYA, from 5 different applicants. The average 510(k) review took 64 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Tester, Electrode/Lead, Electroencephalograph |
| Device class | Class I |
| Regulation | 21 CFR 882.1410 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GYA clearance
Top GYA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| World Precision Instruments, Inc. | 1 | 1988-09-30 |
| E-Z Instruments Co. | 1 | 1986-05-08 |
| General Devices | 1 | 1983-06-08 |
| Cadwell Laboratories, Inc. | 1 | 1982-01-28 |
| Life-Tech Instruments, Inc. | 1 | 1978-09-07 |
Most recent GYA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883869 | World Precision Instruments, Inc. | DERMTRODE | 1988-09-30 | 17 |
| K854396 | E-Z Instruments Co. | RUB E-Z | 1986-05-08 | 189 |
| K830877 | General Devices | AP-CHECK | 1983-06-08 | 82 |
| K820040 | Cadwell Laboratories, Inc. | SC-IT IMPEDANCE TESTER | 1982-01-28 | 21 |
| K781475 | Life-Tech Instruments, Inc. | ELECTRODE IMPEDANCE TESTER-MODEL 500 | 1978-09-07 | 10 |
Recalls for GYA devices
openFDA lists no recalls for product code GYA.
Frequently asked questions
What is FDA product code GYA?
GYA is the FDA product code for tester, electrode/lead, electroencephalograph. It is a Class I device, regulated under 21 CFR 882.1410 and reviewed by the Neurology panel.
What device class is GYA?
Class I, regulation 21 CFR 882.1410. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GYA?
Across 5 cleared submissions the average was 64 days from receipt to decision (median 21).
Which companies have the most GYA clearances?
World Precision Instruments, Inc. (1); E-Z Instruments Co. (1); General Devices (1); Cadwell Laboratories, Inc. (1); Life-Tech Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GYA
- Run a recall and safety report across every GYA manufacturer
- Watch product code GYA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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